- Device
- RX-1 Sleep
- Company
- Vivaquant, Inc. Dba Rhythm Express
- Submission number
- K253148
- Pathway
- 510(k)
- Decision date
- Jun 22, 2026
- Specialty (lead panel)
- Anesthesiology
- Primary product code
- MNR
Source: U.S. FDA AI-Enabled Medical Devices list. The FDA says the list is not comprehensive. Confirm details on the FDA's own record.